A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

Completed · Phase 3 · Has a placebo group

Conditions studied: Bronchoscopy

In brief

A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.

Key facts

Study ID

NCT02296892

Run by

Paion UK Ltd.

People needed

446

Starts

2015-04-01

Expected to finish

2017-03-13

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
• American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
• Body mass index (BMI) ≤ 45.
• Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
• For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
• Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
• Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.

You may not qualify if…

• Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
• Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
• Patients on mechanical ventilation.
• Tracheal stenosis.
• Planned laser bronchoscopy, rigid scope bronchoscopy.
• Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
• Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
• Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
• Patient with a history of drug or ethanol abuse within the past two years.
• Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
• Participation in any previous clinical study with remimazolam.
• Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).

Where it is running

• Pab Clinical Research — Brandon, Florida, United States
• Sun City Office — Sun City Center, Florida, United States
• Laporte County Institute For Clinical Research — Michigan City, Indiana, United States
• The Johns Hopkins Center for Interventional and Pulmonary Care — Baltimore, Maryland, United States
• Washington University School of Medicine/Barnes-Jewish Hospital — St Louis, Missouri, United States
• Unc Division of Pulmonary and Critical Care — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Pinehurst Medical Clinic — Pinehurst, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• S. Carolina Pharmaceutical Research — Spartanburg, South Carolina, United States
• Pulmonary Associates of Richmond — Richmond, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Multicare Institute For Research & Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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